Regulatory Writing Manager

Company: Amgen

Posted: January 12, 2017

Reference ID: R-28920

Amgen is seeking a Regulatory Writing Manager. This role will be based on our main corporate campus in Thousand Oaks, CA or could be managed as a remote work assignment. Job responsibilities include: Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standards Write or oversee the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phase 1 through 4) Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives Write other regulatory submission documents (e.g., RTQs, PIP, white papers, breakthrough therapy applications, orphan drug applications) Manage study timelines for regulatory documents and regulatory submission strategy Act as a functional area representative and lead on product teams Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance Ensure quality of regulatory submission documents at all stages of development Provide expertise and guidance on document design and principles of good medical writing to the department and product teams Participate in departmental meetings, as well as departmental and cross-departmental initiatives Basic Qualifications Doctorate degreeORMaster's degree and 3 years of Writing Regulatory or scientific submission/documents experienceORBachelor's degree and 5 years of Writing Regulatory or scientific submission/documents experienceORAssociate's degree and 10 years of Writing Regulatory or scientific submission/documents experienceORHigh school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience Preferred Qualifications MS or higher degree in biology, chemistry or other scientific discipline 5+ years of experience in writing clinical and regulatory documents Ability to effectively operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment Ability to analyze medical data and interpret its significance Advanced knowledge of scientific/technical writing and editing and of related regulatory guidance (e.g., ICH) governing regulatory submission documents and industry compliance Advanced written/oral communication skills and attention to detail Understanding and application of principles, concepts, theories and standards of scientific/technical field Strong time and project management skills, negotiating skills, and perseverance with a drive for results Knowledge of management skills and supervising the work of others Strong leadership in a team environment Strong negotiator Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. #LI-POST Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.